(252 days)
Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. The prostheses can be screw or cement retained to the abutment.
The Alpha Dent Implants Dental Implants System is indicated also, for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The Alpha Dent Implant Active Conus (IAK), Implant Classic Conus (ICK), Implant Active Bio (IAB) Dental Implants System consists of one or two stage Endosseous form dental implants, with same platform of implant/prosthetics abutments connection- internal hexagon for anti-rotation and internal cone, and It is intended to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
The Alpha Dent Implants Dental Implants System is a medical device intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous patients. It aims to provide support for prosthetic devices (artificial teeth) and restore chewing function. The system is designed for single-tooth or multiple-teeth applications, with prostheses that can be screw or cement-retained to the abutment. It is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The device's acceptance criteria and the study that proves it meets these criteria are detailed below:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Alpha Dent Implants Dental Implants System are primarily based on demonstrating substantial equivalence to predicate devices (K181138 and K180968) in terms of intended use, materials, performance, and safety. The performance criteria are derived from relevant international standards and the results of non-clinical testing.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Evidence |
|---|---|---|
| Intended Use | The device's intended use and indications for use should be substantially equivalent to previously cleared predicate devices. | The subject device's intended use and indications for use are previously cleared by FDA for the reference device K180968 (Alpha Dent Dental Implants Ltd) and are stated to be the same as the primary predicate K181138 (IS-III active System, Neobiotech Co., Ltd). |
| Materials | Implants and prosthetic components must be manufactured from medical-grade materials that comply with relevant standards. | Implants and abutments are manufactured from Titanium alloy (Ti 6Al 4V ELI) complying with ASTM F 136 Standard. This material is consistent with the predicate devices (Ti Grade 5 (Ti6AL4V-ELI) ASTM F136-13 for K180968 and Ti CP4 of ASTM F67 for K181138, though the subject device uses a higher grade Ti alloy). |
| Biocompatibility | The device must demonstrate biocompatibility for its intended use, in accordance with established biological evaluation standards. | Biocompatibility evaluation was conducted in accordance with ISO 10993-1 and FDA guidance. All biological endpoints were met, establishing the device as biocompatible. SEM and Surface analysis (EDS) after the anodize process demonstrated morphology and cleanliness. |
| Sterilization & Packaging | The device must be provided sterile (implants) with a minimum sterility assurance level (SAL) of 10⁻⁶, and packaging must maintain sterility for the specified shelf life. Non-sterile components (abutments) must have validated sterilization instructions for the end-user. | Implants are packaged in a clean room (ISO CLASS 7) and provided with a SAL of 10⁻⁶, validated per ANSI/AAMI/ISO 11137-1 and EN ISO 11137-2. Accelerated aging per ASTM-F-1980 was applied to substantiate a 5-year shelf life, with a real-time study ongoing. Abutments are supplied non-sterile, and moist heat sterilization for end-users was validated per ANSI/AAMI/ISO 17665-1, demonstrating a 6-log reduction of Geobacillus stearothermophilus. |
| Pyrogenicity | The device must meet pyrogen limit specifications. | LAL Endotoxin Analysis demonstrated pyrogenicity met specifications, with a testing limit of 20 EU/device, based on USP <161>. |
| Mechanical Performance | The implants must withstand dynamic fatigue loads per ISO 14801, demonstrating sufficient mechanical strength and durability. Performance should be comparable to the predicate device. For prosthetic components, the implant-abutment connection design and general shape should be similar to recognized predicate devices. The thread type variation for internal thread should not affect structural performance and offer same pitch design. | Static and dynamic compression performance tests were conducted per ISO 14801. The worst-case scenario (smallest diameter, longest implant, 25° abutment) was selected. The measured fatigue limits for Alpha Dent implants were similar to those of the predicate device Neobiotech (K181138) (metal dental implants with a diameter of 3.5 mm). The run-out bending moment was within similar values. The implant/abutment connection design, general shape, and dimensions are compared to predicate K180968. The difference in internal thread type (M1.80-6H vs 1-72 UNF 2B) was deemed not to affect structural performance as both have identical outer diameter (1.80 mm) and same pitch design. |
| Design/Technological Characteristics | The device's technological characteristics, including implant/abutment connection design, surface treatment, general shape, and dimensions, should be comparable to predicate devices. | The implant/abutment connection design (internal hexagon for anti-rotation and internal cone) is stated to be the same as the primary predicate (K181138). The surface treatment (anodized layer), general shape, and dimensions are substantially equivalent to the reference predicate (K180968). While there is a slight difference in design and dimensions between the primary predicate and the subject device, and a minor difference in internal thread type, these were considered not to affect structural performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" in terms of number of devices for each non-clinical test (e.g., how many implants were subjected to fatigue testing). It generally refers to "the implant used in the testing was the smallest in diameter and the longest in length available with this system of implants," indicating a worst-case selection for mechanical performance.
The data provenance is from non-clinical bench testing conducted by Alpha Dent Implants GmbH, not from human or animal subjects. Therefore, there is no information on country of origin of data, or whether it was retrospective or prospective in the sense of clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. The "test set" in this context refers to non-clinical bench testing data and engineering analysis, not clinical data requiring expert review for ground truth establishment. Equivalence is established through comparison to predicate devices and adherence to international standards.
4. Adjudication Method for the Test Set
This question is not applicable. There was no "test set" of clinical cases requiring adjudication by experts. The substantiation relies on engineering judgment, comparison to predicate devices, and demonstrated compliance with recognized standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document explicitly states: "No clinical studies were performed." This is a 510(k) submission primarily relying on substantial equivalence to legally marketed predicate devices through non-clinical performance testing and comparative analysis of design and materials.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The Alpha Dent Implants Dental Implants System is a physical medical device (dental implants and associated prosthetic components), not an AI algorithm or software. Therefore, there is no "standalone" algorithm performance to assess.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the safety and effectiveness of the device is established by:
- Substantial Equivalence to Predicate Devices: Comparing the new device's intended use, technological characteristics (design, materials, surface treatment), and performance data to those of one or more legally marketed predicate devices (K181138 and K180968) that have already been determined safe and effective.
- Adherence to Recognized International Standards: Compliance with standards such as ASTM F 136 (material), ISO 10993-1 (biocompatibility), ANSI/AAMI/ISO 11137-1 and EN ISO 11137-2 (sterilization), USP <161> (pyrogenicity), ASTM-F-1980 (accelerated aging/shelf life), and ISO 14801 (dynamic fatigue test for implants).
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of this device submission, as it is a physical medical device and not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Alpha Dent Implants GmbH Simha Sibony Regulatory Affairs Consultant Hanauer Street 8 Pforzheim, 75181 GERMANY
November 1, 2021
Re: K210499
Trade/Device Name: Alpha Dent Implants Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 20, 2021 Received: September 27, 2021
Dear Simha Sibony:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K210449
Device Name Alpha Dent Implants Dental Implants System
Indications for Use (Describe)
Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or the mandbular arch, to support crowns, bridges, or over dentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. The prostheses can be screw or cement retained to the abutment.
The Alpha Dent Implants Dental Implants System is indicated also, for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
C)
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font, and to the right of the word "IMPLANTS" is a small German flag.
510(k) Summary
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Alpha Dent Implants Dental Implants System
1. GENERAL INFORMATION
| Date Prepared: | October 18th, 2021 |
|---|---|
| Common Name: | Alpha Dent Implants Dental Implants System |
| Classification Name: | Implant, Endosseous, Root-Form |
| Class: | II |
| Product Code: | DZE |
| Subsequent product code | NHA |
| CFR section: | 21 CFR872.3640 |
| Device panel: | Dental |
| Legally Marketed PrimaryPredicate Device: | K181138 - IS-III active System, Neobiotech Co., Ltd |
| Legally MarketedReference Devices: | K180968 – Alpha Dent Implants Ltd ; K181381-A.B. Dental Devices Ltd |
| Submitter: | Dr Boris Simanovski -CEOAlpha Dent Implants GmbHHanauer Str.8, 75181 Pforzheim, GermanyE: dr.simanovski@gmail.comTel: +4917678531156 |
| Contact: | Simha Sibony- Regulatory Affairs ConsultantGMRE Ltd21 Hazamir St.Nahariya 2226024IsraelEmail: simhasibony@gmail.comTel: +972-52-654-6625 |
2. DEVICE DESCRIPTION
The Alpha Dent Implant Active Conus (IAK), Implant Classic Conus (ICK), Implant Active Bio (IAB) Dental Implants System consists of one or two stage Endosseous form dental implants, with same platform of implant/prosthetics abutments connection- internal hexagon for anti-rotation and internal cone, and It is intended to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. To the right of the word "IMPLANTS" is a small image of the German flag.
IMPLANTS 2.1
IMPLANT ACTIVE KONUS 2.1.1
Alpha Dent Active Konus are implants with tapered external conical shape that mimics the shape of the natural tooth root. These implants are used at two stage protocol for all types of bones. Alpha Dent Active Konus are spiral, conic, with deep and sharp double threads for self- retention.
Active Konus implant has a platform with an inner cone and a hexagon for positioning. This type of platform allows creating a conical connection with suprastructures.
Narrow Platform 2,1 mm
| IAK- Implant Active Konus | Predicate K181138 |
|---|---|
| Length 8, 10, 11.5, 13 mm Diameter 3.3 mm | |
| Length 8, 10, 11.5,13 mm Diameter 3.75 mm | |
| Length 8, 10, 11.5,13 mm Diameter 4.2 mm | |
| Length 8, 10, 11.5,13 mm Diameter 5.0 mm | |
| Length 8, 10, 11.5,13 mm Diameter 6.0 mm | |
| Made of titanium alloy Ti 6Al 4V ELI |
2.1.2 IMPLANT CLASSIC KONUS
Classic Konus implant has a platform with an inner cone and a hexagon for the positioning of dental structures. This type of platform allows creating a conical connection with suprastructures. The 3.3 mm diameter implants are installed in front and lateral parts (canine teeth, incisors, premolar teeth).
Narrow Platform 2.1 mm
| ICK- Implant Classic Konus | Predicate K181138 |
|---|---|
| Length 10, 11.5, 13 mm Diameter 3.3 mm | |
| Length 8, 10, 11.5, 13 mm Diameter 3.75 mm | |
| Length 8, 10, 11.5, 13 mm Diameter 4.2, mm | |
| Length 8, 10, 11.5,13 mm Diameter 5.0 mm | |
| Length 8, 10, 11.5,13 mm Diameter 6.0 mm | |
| Made of titanium alloy Ti 6Al 4V ELI |
2.1.3 IMPLANT ACTIVE BIO
Active Bio is a conical-shaped implant with a helical thread. It is used under one- or two-steps procedure in all bone types.
Narrow Platform 2,1 mm
| IAB - Implant Active Bio | Predicate K181138 | |
|---|---|---|
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. To the right of the word "IMPLANTS" is a small graphic that appears to be the German flag.
Image /page/5/Picture/1 description: The image shows a close-up of a dental implant. The implant is made of metal and has a screw-like shape. The threads of the screw are visible, and there are also some holes in the implant. The implant is designed to be inserted into the jawbone to support a false tooth.
Length 8, 10, 11.5,13 mm Diameter 3.3 mm Length 8, 10, 11.5, 13 mm Diameter 3.75 mm Length 8, 10, 11.5, 13 mm Diameter 4.2, mm Length 8, 10, 11.5, 13 mm Diameter 5.0 mm Length 8, 10, 11.5, 13 mm Diameter 6.0 mm Made of titanium alloy Ti 6Al 4V ELI
2.2 PROSTHETIC COMPONENTS
The Alpha Dent Implants Dental Implants System includes prosthetics components that consist of healing caps, Cemented restorations: straight and angular abutments (regular/narrow/ wide/shoulder/esthetic abutment); Screw retained restorations: Multi unit, Titanium Esthetic abutments; Removable restorations: Ball attachments, Locators.
For all the prosthetic components of the subject device described below, the Implant – abutment connection is same platform with an inner cone and a hexagon for positioning:
NARROW CONICAL PLATFORM 2.1 mm (3.0)
This implant/abutment connection is compatible to all subject device implants: ICK, IAK, IAB
Straight Abutments- cemented retained reconstruction
A variety of titanium straight abutments are available for use in different cases. They are used in the fabrication of cement-retained restorations, single crowns or bridges.
Standard abutments with an extended body are used for thick gums, or when the implant is very deep.
- . Narrow abutments are used in minimal prosthetic space
- . Wide abutments are used in wide prosthetic spaces, mainly for posterior teeth.
● Anatomic abutments have a shape that is contoured to the gingiva to allow for individualization of a prosthetic unit.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha, followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. To the right of the word "IMPLANTS" is a small image of the German flag.
| Image: Abutment 1 | STRAIGHTCONICAL | Straight titaniumantirotational conicalabutment. Abutmentincludes a screw.Available in sizes: 7mm, 9 mm, 11 and 12mm. | |
|---|---|---|---|
| Image: Abutment 2 | STRAIGHTCONICAL | Wide antirotationaltitanium conicalabutment with hexagon.Mainly used in the areaof posterior teeth. | |
| Image: Abutment 3 | STRAIGHTCONICAL | Anatomical titaniumshoulder abutmentstraight conical. | |
| Image: Abutment 4 | STRAIGHTCONICAL | Anatomical titaniumshoulder wide abutmentstraight conical.Available in threeshoulder sizes: 1, 2, 3mm. | |
| TAK3 – TitaniumAbutment Konus | |||
| TAWK 3/9 -Titanium AbutmetWide Konus | |||
| TAK3001/002/003;AnatomicalTitanium ShoulderAbutment | |||
| TAWK3001/002/003– AnatomicalTitanium ShoulderWide Abutment | |||
| TAAK3/015 | 15°,CONICAL | Angular antirotationaltitanium conicalabutment 15° without ashoulder.It is used in cases, whenthe implant is installedat an angle. | |
| Image: abutment |
Angular Abutments - cemented retained reconstruction
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the company name, the word "IMPLANTS" is written in a smaller font. To the right of the word "IMPLANTS" is a small graphic of the German flag.
Angular abutments are used when a change to the axis of the implant is required. Normally used for constructing cement-retained single crowns or bridges. The abutments are available with angles of 15° and 25°.
- Angular, narrow abutments are used in minimal prosthetic space.
- . Angular anatomic abutments have a shape that is contoured to the gingiva. This enables an customization of the prosthetic unit. • Narrow top angular abutment allows minimal technical preparation
Titanium Angulated Abutments (shoulder)
| Image: dental abutment | Angular anatomicaltitanium conicalabutment 15°and 15°with shoulder 1-3 mm. | ||
|---|---|---|---|
| TAAK3/01501/02/ | 15°,CONICAL | It is used for aesthetictasks solving investibular area, andreplicating the shape ofgingival line |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha, followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font, and to the right of the word "IMPLANTS" is a small German flag.
| Image: Dental abutment | TAAK3/025TAAK3/02502 | 25°, CONICAL | Angular anatomical titanium conical abutment 25° and 25° with shoulder 2 mm.It is used for aesthetic tasks solving in vestibular area, and replicating the shape of gingival line. |
|---|---|---|---|
| ------------------------ | -------------------------- | -------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Ball attachment - removable prosthesis
The ball attachment prosthetic is intended to secure a removable prosthesis. The attachment is used in conjunction with a stainless-steel cap and an intermediate silicone insert. Not used for single unit reconstruction
| Image: Dental implant | BAK- Ball Attachment KonusLength; 2, 3,4,5,6mmPlatform :NARROW CONICAL PLATFORM 2.1 mm (3.0)Made of titanium alloy Ti 6Al 4V ELI | A structure with conical ballattachment is used forfixation of removabledenture. A cap made ofstainlesssteel can be included, as wellas an intermediate siliconecap of three differentdegrees of hardness: soft,standard,and strong. |
|---|---|---|
| ----------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Locators with a conical connection is used for removable denture fixation.
| Image: dental implant | LCK3- LocatorsLength; 2, 3,4,5,6 mmPlatform :• NARROW CONICAL PLATFORM 2.1 mm (3.0)Made of titanium alloy Ti 6Al 4V ELI | Locator with a conicalconnection is used forremovable denture fixation.A cap made of stainless steelcan be included, as well as anintermediate silicone cap. |
|---|---|---|
| ----------------------- | ----------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
2.3 AESTHETIC ANTIROTATIONAL ABUTMENT (STRAIGHT MULTI-UNIT)
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. To the right of the word "IMPLANTS" is a small graphic that appears to be the German flag.
Aesthetic antirotational abutment (straight multi-unit) with a sleeve is used in order to restore a bridge with a screw retention.
Screw in with a maximum force of 20 newton
Image /page/9/Picture/3 description: The image shows an AEAK3 - Aesthetic Antirotational Abutment. The abutment has lengths of 1, 2, and 3 mm. The platform is a NARROW CONICAL PLATFORM with a size of 2.1 mm (3.0). The image shows a side view of the abutment.
AESTHETIC ABUTMENT (STRAIGHT MULTI-UNIT) 2.4
Aesthetic abutment (straight multi-unit) with a sleeve is used in order to restore a bridge with a screw retention.
Screw in with a maximum force of 20 newton
All aesthetic abutments are intended only for Multi Unit loaded restoration.
No single unit implant use with aesthetic abutments.
Image /page/9/Picture/9 description: The image shows a 3D rendering of a dental implant. The implant has a screw-like structure at the bottom, a cylindrical body in the middle, and a hexagonal head at the top. The implant is silver in color and appears to be made of metal.
- AEAK+ Aesthetic Abutment Length: 1, 2, 3 mm Platform : ● NARROW CONICAL PLATFORM 2.1 mm (3.0)
2.5 ONE-PIECE ANGULAR MULTI-UNIT 17° /30° CONICAL
Multi-unit system is used for a prosthesis with screw retention.
One-piece angular multi-unit allows rehabilitation at non-parallel implants by correcting the angle.
| 17°/30°Conical | |
|---|---|
| Image: Dental implant | MUBK3.0 – One Piece Angular Multi-Unit 17°/30° ConicalLength:1, 2, 3 mmPlatform : |
| • NARROW CONICAL PLATFORM 2.1 mm (3.0) |
- 2.6 HEALING CAP KONUS 3
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. To the right of the word "IMPLANTS" is a small image of the German flag.
The titanium conical healing cap is installed on the implant and is designed to form the gingival margin and gingival papilla. Available in the following heights: 2, 3, 4, 5, 7mm. The size is determined by the height of the gums.
Image /page/10/Picture/2 description: The image shows a 3D rendering of a dental implant. The implant has a cylindrical head with a slightly rounded top and several horizontal grooves. Below the head, the implant tapers down to a narrower, threaded screw-like section, which is designed to be inserted into the jawbone.
Healing cap konus 3 (HCK3) Length: 2, 3, 4, 5, 7 mm
HEALING CAP WIDE KONUS 3 2.7
Image /page/10/Picture/5 description: The image shows a close-up of a metal screw with a large, flat head. The screw has a cylindrical body with threads that run along its length. The head of the screw is wider than the body and has a smooth, rounded surface. The screw appears to be made of a shiny metal, possibly stainless steel or aluminum. The image is well-lit, and the screw is in focus.
Healing cap wide konus 3 (HCWK3) Length: 2, 3, 4, 5 mm
3. MATERIALS:
The implants are manufactured from Titanium alloy (Ti 6Al 4V ELI) complying with standard ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for surgical implant applications.
4. INDICATION FOR USE
Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. The prostheses can be screw or cement retained to the abutment.
The Alpha Dent Implants Dental Implants System is indicated also for immediate loading when primary stability is achieved and with appropriate occlusal loading.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. To the right of the word "IMPLANTS" is a small graphic that appears to be the German flag.
5. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES Alpha Dent Implants Dental
Implants System subject to this submission is substantially equivalent to K181138 - IS-III active System, Neobiotech Co., Ltd in terms of intended use, implant/abutment connection design, materials used, safety and performance testing.
The surface treatment, packaging and sterilization are substantially equivalent to K180968 – Alpha Dent Dental Implants Ltd.
Evidence of equivalence has been demonstrated through:
- The Alpha Dent Implants Dental Implants System subject device's intended use and indications for use were previously cleared by FDA for the reference device K180968 – Alpha Dent Dental Implants Ltd.
-
- The technical characteristics of the Alpha Dent Implants System subject devices' are similar to those of reference device K180968 – Alpha Dent Dental Implants Ltd.
-
- Safety and performance testing of the Alpha Dent Implants System subject device's are similar to those of the predicate device K181138 - IS-III active System, Neobiotech Co.
Therefore, the Alpha Dent Implants Dental Implants System subject device is substantially equivalent to the predicate devices in terms of intended use, materials used, and technological characteristics.
| Device Name: | Implant IS-III activeNeobiotechPrimary Predicate | ImplantALPHA DENTReference PredicateImplant Active (IA)ALPHA DENTReference Predicate | Implant Classic (IC)ALPHA DENTReference Predicate | Implant Active Bio (IAB)Implant Active Conus (IAK)Implant Classic Conus (ICK)ALPHA DENT |
|---|---|---|---|---|
| 510K Number | K181138 | K180968 | K180968 | Current Submission |
| Indications for use | [1] below this table | [2]below this table | [2]below this table | [2]below this table |
| Patient Population | Edentulousorpartially | Edentulousorpartially | Edentulousorpartially | Edentulousorpartially |
| edentulous individuals | edentulous individuals | edentulous individuals | edentulous individuals | |
| Material | TI CP4 of ASTM F67. | Ti Grade 5 (Ti6AL4V- | Ti Grade 5 (Ti6AL4V-ELI) | Ti Grade 5 (Ti6AL4V-ELI) |
| ELI) ASTM F136-13 | ASTM F136-13 | ASTM F136-13 | ||
| Outer Diameters(mm) | 3.5; 4.0; 4.5; 5.0; 6.0; 7.0" | 3.3; 3.75; 4.2; 5.0 | 3.3; 3.75; 4.2; 5.0 | 3.3; 3.75; 4.2; 5.0; 6.0 |
| Length (mm) | 7.3;8.5; 10.0; 11.5; 13.0;15.0" | 8.0; 10.0; 11.5; 13.0; 16.0 | 8.0; 10.0; 11.5; 13.0; 16.0 | 8.0; 10.0; 11.5; 13.0; 16.0 |
| Thread Design | Self-tapping | Self-tapping | Self-tapping | Self-tapping |
| Recommendedtype of Bone | Bone - All Types | Soft Bone(Type 3-4) | Hard Bone(Type 1-2) | Bone - All Types |
| Implant/abutmentconnection | Internal Hexagon for anti-rotation and Internal Cone | Internal Hex Connection2.4mm | Internal Hex Connection2.4mm | Internal Hexagon for anti-rotation and Internal Cone |
| Placement in Bone | Bone Level | Bone Level | Bone Level | Bone Level |
| Surfacetreatments | SLA | Anodized layer | Anodized layer | Anodized layer |
| Clinical procedure | This product is a root typefixture which is inserted inthe alveolar bone. Itreplaces the functions ofthe missing teeth as adental implant fixture. | Immediate loading or forloading after aconventional healingperiod | Immediate loading or forloading after aconventional healingperiod | Immediate loading or forloading after aconventional healingperiod |
| Sterility | Gamma irradiation | Gamma irradiation | Gamma irradiation | Gamma irradiation |
Table 1: Implants Comparison Table
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha, followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. To the right of the word "IMPLANTS" is a small image of the German flag.
[1] The IS-III Active Fixture is intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the wing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
[2] Alpha Dent Implants Dental Intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single teeth applications. The prostheses can be screw or cement. The Alpha Dent Implants Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading
Table 2: Implants' Prosthetics Comparison Table
| Device Name: | Healing caps for implants with internal hexagon connectionManufacturer: AlphaDent | Healing caps for implants with conical connection.Manufacturer: AlphaDent |
|---|---|---|
| 510K Number | K180968 | Current submission |
| Connection | Internal hexagon connection | Conical hexagon |
| Material | Grade 5 (Ti6AL4V-ELI) | Grade 5 (Ti6AL4V-ELI) |
| Size | HC:Diameter: 4.5 mmLength: 2,3,4,5 and 7 mmPlatform: 3.75 mmHCW:Diameter: 5.5 mmLength: 2,3,4,5Platform: 3.75 mm | HCK 3:Diameter: 4.2 mmLength: 2,3,4,5 and 7 mmPlatform: 2.80 mmHCWK 3:Diameter: 5.5 mmLength: 2,3,4,5Platform: 2.80 mm |
| Principle of Operation | This product is healing cap to formation appropriate gingival shape during the soft tissue healing period combined with implant. This product should be removed when the superstructure is set up. | This product is healing cap to formation appropriate gingival shape during the soft tissue healing period combined with implant. This product should be removed when the superstructure is set up. |
| Device Name: | Abutments for implants with internal hexagon connectionManufacturer: AlphaDent | Abutments for implants with conical connection.Manufacturer: AlphaDent |
| 510K Number | K180968 | Current submission |
| Connection | Internal Hexagon connection | Conical hexagon |
| Sterility: | Non-Sterile | Non-Sterile |
| Material | Grade 5 (Ti6AL4V-ELI) | Grade 5 (Ti6AL4V-ELI) |
| Size/geometry | TA - Straight anti rotation abutmentTA-Standard:Diameter: 4.5 mm;Length: 7, 9, 12 mmPlatform: 3.75 mmTA0XX - Titanium Abutment ShoulderDiameter: 4.5 mmLength: 1, 2, 3 mmPlatform: 3.75 mmTAW-Straight anti rotation abutmentTAW-Wide:Diameter: 5.5mm;Length: 9, 12 mmPlatform: 3.75 mmTA0XXW- Titanium Abutment Shoulder WideDiameter: 5.5 mm | TAK 3XX - Titanium Abutment Konus.Diameter: 3.35 mmLength: 7, 9, 12 mmPlatform: 2.80 mmTAK 3/0XX - Titanium Abutment Konus ShoulderDiameter: 4.2 mmLength: 1, 2, 3 mmPlatform: 2.80 mmTAWK 3/9 - Titanium Abutment Wide KonusDiameter: 5.0 mmLength: 9 mmPlatform: 2.80 mmTAWK 3/0XX - Titanium Abutment Shoulder Wide KonusDiameter: 5.5 mmShoulder: 1, 2, 3 mm |
| TAA0XXYY - Titanium AngulatedAbutment-shoulderDiameter: 4.5 mmShoulder: 1, 2 , 3 mmPlatform: 3.75 mmAngle: 15 deg and 25 deg.TAA - Angular AbutmentsDiameter: 4.80 mmPlatform: 3.75 mmAngle: 15 deg and 25 deg. | TAAK3/0XXYY - Angulated Titanium Abutment KonusDiameter: 4.2 mmShoulder: 1, 2 , 3 mmPlatform: 2.80 mmAngle: 15 deg and 25 deg.TAAK3/0XX - Angulated Titanium Abutment KonusDiameter: 3.35 mmPlatform: 2.80 mmAngle: 15 deg and 25 deg. | |
| Principle of Operation | It is indicated for screw retained singletooth or cement retained single toothand bridge restorations. | It is indicated for screw retained single tooth or cementretained single tooth and bridge restorations. |
| Device Name: | Ball Attachments for implants withinternal hexagon connectionManufacturer: AlphaDent | Ball Attachments for implants with conical connection.Manufacturer: AlphaDent |
| 510K Number | K180968 | Current submission |
| Connection | Internal hexagon connection | Conical hexagon |
| Material | Grade 5 (Ti6AL4V-ELI) | Grade 5 (Ti6AL4V-ELI) |
| Size | BA- Ball attachmentDiameter: 4.0 mmHeights: 1, 2, 3, 4, 5, 6 mmPlatform: 3.75 mm | BAK3 - Ball Attachment KonusDiameter 4.2 mmHeights: 2, 3, 4, 5, 6 mmPlatform: 2.80 mm |
| Principle of Operation | Used for implant retained mucosa-supported restorations, such asoverdentures where the patient is fully | Used for implant retained mucosa-supported restorations,such as overdentures where the patient is fully edentulousin the arch to be restored. |
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha, followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font, and a small German flag is to the right of the word "IMPLANTS".
| Antirotational Esthetic Abutment for implantswith internal hexagon connectionManufacturer: AlphaDent | Antirotational Esthetic Abutment for implantswith conical connection.Manufacturer: AlphaDent | |
|---|---|---|
| 510K Number | K180968 | Current submission |
| Connection | Internal hexagon connection | Conical hexagon |
| Material | Grade 5 (Ti6AL4V-ELI) | Grade 5 (Ti6AL4V-ELI) |
| Size | AEA - Esthetic AntirotationalDiameter: 4.7 mmHeights: 1, 2, 3 mmPlatform: 3.75 mm | AEAK - Antirotational Esthetic Abutment KonusDiameter: 4.7 mmHeights: 1, 2, 3 mmPlatform: 2.80 mm |
| Principle of Operation | Esthetic Screw Abutment is designed for the screwretained rehabilitation process on single ormultiple units. | Esthetic Screw Abutment is designed for the screwretained rehabilitation process on multiple units. |
| Similarities | The subject and primary predicate have same indications for use, functions, materials, surface treatment, general shape (design) and dimensions. | |
| Esthetic Abutment for implants with internalhexagon connectionManufacturer: AlphaDent | Esthetic Abutment for implants with conicalconnection.Manufacturer: AlphaDent | |
| 510K Number | K180968 | Current submission |
| Connection | Internal hexagon connection | Conical hexagon |
| Material | Grade 5 (Ti6AL4V-ELI) | Grade 5 (Ti6AL4V-ELI) |
| Size | TAE - Titanium Esthetic AbutmentsDiameter: 4.3 mmHeights: 1, 2, 3 mmPlatform: 3.75 mm | AEAK + - Esthetic Abutment KonusDiameter: 4.3 mmHeights: 1, 2, 3 mmPlatform: 2.80 mm |
| Principle of Operation | Esthetic Screw Abutment is designed for the screwretained rehabilitation process on single ormultiple units. | Esthetic Screw Abutment is designed for the screwretained rehabilitation process on multiple units. |
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font, and to the right of the word "IMPLANTS" is a small image of the German flag.
| One-Piece angular multi-unit for implants with | One-Piece angular multi-unit for implants with | |||
|---|---|---|---|---|
| Device Name: | internal hexagon connection | conical connection. | ||
| Manufacturer: AlphaDent | Manufacturer: AlphaDent | |||
| 510K Number | K180968 | Current submission | ||
| Material | Grade 5 (Ti6AL4V-ELI) | Grade 5 (Ti6AL4V-ELI) | ||
| Size | MUB - Multi-Unit Base | MUBK3 – One-Piece angular multi-unit | ||
| Diameter: 4.3 mm | Diameter: 4.3 mm | |||
| Heights: 1, 2, 3 mm | Heights: 1, 2, 3 mm | |||
| Platform: 3.75 mm | Platform: 2.80 mm | |||
| Angle: 17 /30 deg | Angle: 17/30 deg. | |||
| Multi-unit Angled Base is a pre-manufactured | Multi-unit Angled Base is a pre-manufactured | |||
| Principle of Operation | prosthetic component directly connected to the | prosthetic component directly connected to the | ||
| Endosseous dental implant and is intended for use | Endosseous dental implant and is intended for use | |||
| as an aid in prosthetic rehabilitation. | as an aid in prosthetic rehabilitation. | |||
| Similarities | The subject and primary predicate have same indications for use, functions, materials, surface treatment, | |||
| general shape (design) and dimensions. | ||||
| Locators for implants with internal hexagon | Locators for implants with conical connection. | |||
| Device Name: | connection | Manufacturer: AlphaDent | ||
| Manufacturer: A.B.Dental | ||||
| 510K Number | Current submission | |||
| K181381 | ||||
| Material | Grade 5 (Ti6AL4V-ELI) | |||
| Grade 5 (Ti6AL4V-ELI) | ||||
| Size | P25 - A.B. LOC Abutments | LCK3 — Locator | ||
| Diameter: 3.75 mm | Diameter: 3.75 mm | |||
| Head diameter: 3.85 mm | Head diameter: 3.85 mm | |||
| Heights: 0, 1, 2, 3, 4, 5, 6, 7 mm | Heights: 2, 3, 4, 5, 6 mm | |||
| Platform: 3.75 mm | Platform: 2.80 mm | |||
| Used for implant retained mucosa-supported | Used for implant retained mucosa-supported | |||
| restorations, such as overdentures where the | restorations, such as overdentures where the | |||
| Principle of Operation | patient is fully edentulous in the arch to be | patient is fully edentulous in the arch to be |
Similarities:
The subject device and primary predicate(K181138) have the same conical Hexagon Implant/abutment connection.
The subject device and reference predicate (K180968) have same indications for use, materials, surface treatment, general shape (design) and dimensions, function (implant/abutment range) and packaging (sterile barrier).
Differences: There is a slight difference in design and dimensions between primary predicate Neobiotech (K181138) and the subject device AlphaDent Konus.
The difference is in the implant/abutment connection
There is a minor difference in the type of internal thread M1.80-6H for the Neobiotech predicate device and 1-72 UNF 2B for Alpha Dent subject device. Both implants feature have identical thread outer diameter of 1.80 mm and therefore the thread type variation will not affect structural performance of the implant, furthermore both implants' threads offer same pitch design and therefore deemed equivalent.
6. NON-CLINICAL TEST
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font, and next to it is a small graphic that appears to be the German flag.
The Implants are packaged in clean room ISO CLASS 7 using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10° validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
The components are manufactured from medical grade Titanium alloy (Ti 6Al 4V ELI) per ASTM F 136. Biocompatibility evaluation was conducted in accordance with ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing and, FDA guidance Use of International Standard ISO 10993-
1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
The biocompatibility evaluation established that all biological endpoints were met and that the device is biocompatible for its intended use.
SEM and Surface analysis (EDS) after Anodize process demonstrated the morphology and cleanliness of the final product.
Sterilization validation tests were conducted in compliance with ANSI/AAMI/ISO 11137-1 and EN ISO 11137-2 in order to ensure safety and effectiveness related to Alpha Dent Implants Dental Implants System. Test results have demonstrated that the SAL of 106 was achieved and all testing requirements were met.
Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile." The method used to determine that the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on USP <161>.
Accelerated aging per ASTM-F-1980 have been applied on the final packaging followed by validating package integrity in order to substantiate 5 years shelf life.
Real Time shelf life study is ongoing.
Static and dynamic compression performance test was conducted per ISO 14801- Dentistry-Implants-Dynamic fatigue test for Endosseous Dental implants.
The worst case scenario was chosen based on the FDA guideline for Endosseous, root-form implants. The implant used in the testing was the smallest in diameter and the longest in length available with this system of implants. The 25° abutment was chosen as worst case combination prosthetic component.
Alpha Dent implants that are subject to this submission have performed as good as the predicate-Neobiotech. The measured fatigue limits fall similar, compared to the Neobiotech, and the run-out bending moment in these tests was within similar values than predicate devices Neobiotech (metal dental implants with a diameter of 3.5 mm).
Therefore, we are confident that Alpha Dent Implants can rely on these results to define Substantial equivalence to predicate device.
Abutments are supplied Non sterile and are to be sterilized by end user by moist heat sterilization. Moist heat Sterilization for Abutments was validated in compliance with ANSI/AAMI/ISO 17665-1 and the test results demonstrated that the sterilization process for abutments as stated by Alpha Dent Implants, was able to reduce 6 magnitudes of the biological indicator Geobacillus stearothermophilus based on the "full cycle" approach.
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the Greek letter alpha followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. To the right of the word "IMPLANTS" is a small image of the German flag.
The results of the testing indicate that the Alpha Dent Implants System is substantial equivalent to the predicate devices sighted in this submission.
CLINICAL TEST
No clinical studies were performed.
CONCLUSION
Based on the analysis of the comparison between the predicate device and the subject device and the performance evaluation results contained in this premarket notification, it was concluded that the proposed device is substantially equivalent to the legally marketed predicate devices (primary and reference devices). Testing data shows that the subject device does not present questions of safety or effectiveness that were not addressed by Alpha Dent Implants. Substantial equivalence to the predicate devices were established based on the existing performance tests provided in this 510(k) Submission. The Active Bio (IAB), Active Konus (IAK), Classic Konus (ICK) implants and the predicate Implant IS-III Active that was previously cleared under 510(k) number K181138 are both intended for the same use, and are operated using equivalent clinical procedures. The reference to the Classic(IC) and Active(IS)implants, cleared under K180968, was made in order to support the indications for use, materials, surface treatment, general shape (design) and dimensions, function(implant/abutment range),packaging (sterile barrier)and sterilization.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.